Application of pharmaceutical compositions in manufacturing medications for treatment of diabetic ulcers

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to the pharmaceutical industry, namely to a pharmaceutical composition for treatment of a diabetic ulcer. Application of the pharmaceutical composition in manufacturing a pharmaceutical preparation in the area ofan extremity or on a body surface, or in manufacturing a dressing material for treatment of the diabetic ulcer, where the pharmaceutical composition consists of an edible bee wax, prepared on the basis of the sesame oil extract of rhizome of Scutellaria - Huangqin (Huang Qin), rhizome of Coptis - Huanglian (Huang Lian), bark of Phellodendron- Huangbai (Huang Bai), earthworm and poppy capsule, taken in a specified ratio. The dressing material for treatment of the diabetic ulcer in the area of the extremity or on the body surface, where the said dressing material contains the pharmaceutical composition, consisting of: edible bee wax, prepared on the basis of sesame oil extract of rhizome of Scutellaria - Huangqin (Huang Qin), rhizome of Coptis - Huanglian (Huang Lian), bark of Phellodendron- Huangbai (Huang Bai), earthworm and poppy capsule, taken in a specified ratio. The first aid kit for treatment of the diabetic ulcer in the area of the extremity or on the body surface.

EFFECT: composition possesses an expressed healing activity in treatment of the diabetic ulcers.

10 cl, 20 dwg, 1 tbl, 13 ex

 

The scope of the invention

This invention relates to the use of pharmaceutical compositions in the manufacture of pharmaceutical products for the treatment of diabetic ulcers in the field of limb or on the body surface or in the manufacture of the dressing material. This invention also relates to the variety of dressings for the treatment of diabetic ulcers in the field of limb or on the body surface and to the appropriate first aid kit that contains the specified dressings.

Prior art

In the patent of China ZL931002761 described pharmaceutical composition for treating thermal injuries); this indicated the pharmaceutical composition consists of (A) 3-15% food grade beeswax and (C) 85-97% prepared on the basis of sesame oil extract of Huangqin (Huang-Qin), Huanglian (Juan-lane), Huangbai (Huang Bai), earthworm and poppy capsule, based on the total weight of the pharmaceutical composition. In prepared on the basis of sesame oil extract of dry raw material, each of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, is 2-10 wt.% based on the total weight of sesame oil.

In addition, the pharmaceutical composition for treating thermal injuries is mainly used in warm-blooded mammals or man the ESA for the treatment of thermal injuries, including burns, especially burns a large area burns of boiling liquid (or steam), chemical burns, etc. It also can be used for the treatment of open skin lesions and ulcers in humans, including ulcer wound, infected wound surface, vaginitis, cervical erosion, hemorrhoids, bedsores ulcer, wound surface, frostbite and local cooling of the body, etc.

Terminology

1. "Pharmaceutical composition described in this invention or pharmaceutical composition of the present invention". It's a pharmaceutical composition consisting of (A) 3-15% food grade beeswax and (C) 85-97% prepared on the basis of sesame oil extract of Huangqin (rhizomes of Baikal skullcap (Scutellaria baicalensis Georgi)), Huanglian (rhizomes of coptis Chinese (Coptis chinensis Franch), coptis deltoid (C. deltoidea C.Y.Cheng Hsiao et) or Coptis. teeta Wall), Huangbai (cortex velvet tree Chinese {Phellodendron chinense Schneid) or velvet tree Amur (P. amurense Rupr.)), earthworm and poppy capsule, based on the total weight of the pharmaceutical composition. In prepared on the basis of sesame oil extract of dry raw material, each of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, is 2-10 wt.% based on the total weight of sesame oil.

2. The ulcer. Specifications the leaves in this area agree, the plague is one of the common diseases and the treatment of ulcers is a common practice physicians in clinics. Although the definition of ulcers may seem obvious, many experts do not particularly know the difference between a wound and ulcer. In General, tissue damage, reaching the dermis or subcutaneous tissue, can be called ulcers, purulent ulcer rounded, Dating back at some depth, called festering wound, and a small, very deep, like a hole plague called the fistulous opening. Lever (Lever) was determined by the plague as a partial lesion of the dermis and epidermis scar left after healing. On the other hand, according to the pathological anatomy of Anderson (Anderson's Pathology) it is believed that the inflammation that develops near the surface of the tissue or organ, has a strong inflammatory effect and leads to necrosis of Danu, and in the end after the detachment of necrotic tissue ulcers. So in dermatology, from the point of view of histology and morphology, the plague is a partial lesion of the dermis and epidermis, and it is not necessary for the presence of inflammation as prerequisites. However, in the pathology of the first in the surface layer of the body develops inflammation and ulcer occurs after exfoliation of necrotic tissue. Thus, it is possible to see that the wound falls into the category of ulcers in dermatology, but n is in pathology.

Regarding the relationship between wound and ulcer Siemens emphasized: "the wound is not treated in the first moment, usually develops secondary infection, after which the granulation tissue will grow and cover the bottom of the wound, the wound should be called the plague". It should be noted that in China, experts sometimes call this kind of wound surface "open wound" and classify it as ulcer wound origin.

3. Skin ulcer. Experts in this field agree that the skin ulcer is a limited skin lesion affecting the dermis or deeper layers after injury to the skin, and that after healing will remain a scar.

4. Diabetic ulcer. The author of the present invention believes that the diabetic ulcer is an ulcer in the open skin lesions, ulcers wound or ulcer in the above-mentioned value, and is a special kind of ulcers resulting from diabetes and occur in the lower extremities and superficial body tissue with signs of ulcers, and it develops mainly in the lower extremities and it is totally different in terms of etiology or pathogenesis of traumatic ulcers. Currently worldwide there is not yet perfect and effective pharmaceuticals for the treatment of diabetic p is s.

Diabetic ulcer described in the present invention, includes ulcers in the field of limb and ulcers on the surface of the body of a diabetic patient.

The pathogenetic mechanism of diabetic ulcers is very complicated, and until there is a unified and common clear interpretation. In the General case involved three interactive process: angiopathy, neuropathy and immunopathy.

Angiopathy

There are two main types angiopathy, one of which is a pathological change in the large blood vessels; the other is a pathological change in microvessels. These pathological changes lead to ischemia of the soft tissue in the foot and on the surface of the body and ultimately develop into an ulcer.

Neuropathy

Neuropathy is involved in the early pathogenesis of diabetic foot ulcers and is also the most important damaging factor in diabetic foot ulcer. In this pathogenesis of all functions of neurons are affected, but often the first affected is the longest and thinnest of the nerve fiber, including motor nerve that controls the muscles of the foot. The loss of worm-like muscle, its function leads to deformity of the foot, and this causes an increase in pressure or friction in places located at the metatarsophalangeal joint, on the back surface of the toes or the tip of the x toes and the like. These factors can easily lead to ulcers. In addition, damage to the function of the Autonomous nerves occurs in the early stages of neuropathy, causing a number of pathological changes, including arteriovenous anastomosis, decreased tissue perfusion, alopecia, loss of function of the sebaceous and sweat glands. These elements work together to lead to dryness of the skin, the formation of deposits and susceptibility to cracks on the skin.

Immunopathy

The role of immunopathy in diabetic infection is still debated, most researchers believe that ineffective regulation of blood sugar levels can lead to greater exposure of patients to infection. But in reality, humoral immunity in diabetic patients, apparently, does not deviate from the normal, the level of immunoglobulin in the blood is normal or slightly elevated number of b-lymphocytes corresponds to the norm, and in model mice found no antibody response or ineffectiveness in respect of complement fixation.

For example, the main symptoms of diabetic foot are pain in the leg, numbness, foot ulcer and gangrene on the background of acromegaly resulting from angiopathy, neuropathy, and infection of the feet. In clinical practice this condition is commonly referred to as diabetic foot (commonly referred to as a "broken foot"), features ritaumaria major manifestations, below:

1) skin itch, dryness and lack of sweating, cold extremities, swelling and dryness, dark skin, age spots, peeling of the primary hairline;

2) stabbing pain, burning pain, numbness, dysesthesia or numbness of the limbs, the feeling of "cotton feet, duck gait, intermittent claudication and pain at rest;

3) malnutrition tissues of the extremities, weakening of muscle strength, connective ligaments with susceptibility to damage;

4) the protrusion of the heads of the metatarsal bones, the curves of the metatarsophalangeal joints and the shape of the hollow foot (pes arcuatus), corns, hammer toe, claw toe of the foot, Lou Gehrig's disease, bone destruction, which can lead to pathological fracture, etc.;

5) the pulsation of the dorsal artery of the foot is weakened or disappears; deep and superficial reflexes slow down or disappear;

6) dry and cracked skin or blisters on the skin, bloody bubble, erosion, ulcer, gangrene or necrosis of the extremities.

In modern clinical methods diabetic patients frequently suffer from many types of skin lesions, prolonged metabolic disorders, pathological changes of the microvasculature and peripheral nerves, these changed who I am also undoubted causes skin ulcers. Long angiopathy causes sclerotic and stenocereus changes in the blood vessels, especially in the lower extremities, and has a negative effect on blood flow, further leading to malnutrition of the skin. Pathological changes in microvessels can cause reduced blood supply to Indonesia and exacerbate lesions of the autonomic nerves. Pathological changes of the nerves can increase the threshold of cutaneous pain and pressure sensations, and change the point of application of load on the sole, therefore, the infection is often found on the feet, especially the toes. In this situation, if the lesion affects the skin, the healing process is often inefficient, and the skin is very susceptible to secondary infections, ulcers and gangrene of the feet. Inducing factors in the first stage, the onset of the disease is often noticeable to the majority of patients, and the wound is the most important factor. Again, diabetic patients with a diagnosis of athlete's foot, onychomycosis and prolonged use of antibiotics are more susceptible to fungal infection of the feet. In elderly diabetic patients due to prolonged illness, less physical activity, less efficient peripheral blood circulation of the skin ulcer is formed with a high probability. On the other sides of the, hyperglycemia reduces immune function in elderly patients, and the possibility of infection after the formation of ulcers will be significant, at the same time, in severe cases, there may be cellulitis, osteomyelitis, blood poisoning (septicaemia) and so, in these cases, the likelihood of amputation will increase significantly. Typically, diabetic ulcers should be treated using systemic drug therapy, including blood sugar control, anti-infective therapy, improvement of microcirculation and local treatment of wound surfaces, for example, with the use of cephalosporins, lincomycin, penicillin, clarithromycin, acyclovir, amoxicillin and dicloxacillin sodium capsules, the compounds of sulfamethoxazole and the like as a measure to combat infection; topical application ointment mupirocin, etc. But as soon as there is such a diabetic ulcer and will not be any ideal and effective therapy for the treatment of such wounded wound surface, more often to the present time selected surgical amputation. Therefore, in clinical practice it is extremely necessary non-surgical therapy for diabetic ulcers, also there is a great demand for new medical methods or pharmaceutical agents.

Detailed description of the invention

The technical solution the problem in accordance with this present invention is to use the above-mentioned well-known pharmaceutical compositions used for the treatment of thermal injuries, for the treatment of diabetic ulcers in the field of limb or on the body surface (for brevity, diabetic ulcers).

Therefore, the present invention relates to the use of pharmaceutical compositions in the manufacture of pharmaceutical products for the treatment of diabetic ulcers in the field of limb or on the body surface or in the manufacture of the dressing material. Specified pharmaceutical composition consists of (A) 3-15% food grade beeswax and (C) 85-97% prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, based on the total weight of the pharmaceutical composition. In prepared on the basis of sesame oil extract of dry raw material, each of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, is 2-10 wt.% based on the total weight of sesame oil.

The pharmaceutical compositions described in this invention, are intended for outdoor use. Used in modern methods of pharmaceutical agents for external application may include many dosage forms such as solution, tincture, powder, lotion, oil, emulsion, ointment, paste, patch and gel, etc. In the present invention the preferred form for farmaceuticas which their compositions are oil, emulsion, ointment, paste, patch or gel.

The pharmaceutical compositions described in this invention also include a carrier which is pharmaceutically acceptable.

The application of the present invention applies only to the use of the pharmaceutical compositions described in the present invention, in the manufacture of pharmaceutical products for the treatment of diabetic ulcers in the field of limb or on the body surface, in other words, the pharmaceutical compositions described in this invention will be applied topically for the treatment of diabetic ulcers. The present invention relates to the use of the pharmaceutical compositions described in the present invention, in the manufacture of pharmaceuticals used to treat essentially of diabetes, in other words, the present invention relates to pharmaceutical compositions described in the present invention as pharmaceutical products used to treat essentially of diabetes itself.

The present invention furthermore relates to the variety of dressings for the treatment of diabetic ulcers in the field of limb or on the body surface, while specified in this description dressings provides a pharmaceutical composition consisting of the following ingredients: (A) 3-15% food PCLI the CSOs wax and (C) 85-97% prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, based on the total weight of the pharmaceutical composition. In prepared on the basis of sesame oil extract of dry raw material, each of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, is 2-10 wt.% based on the total weight of sesame oil.

Medical cotton gauze and medical bandage are the preferred forms specified in this description and dressings.

The present invention also relates to variants of the kit, which includes pharmaceutical compositions described in the present invention, or specified in this description dressings and instructions for use. The kit included these pharmaceutical compositions or specified dressings containing these pharmaceutical compositions together with them put at least one copy of the instructions for use, which makes use of the kit of the present invention in clinical practice more convenient.

In the present invention diabetic ulcers were subjected to treatment with the pharmaceutical compositions described in the present invention, and achieved satisfactory therapeutic efficacy. In the treatment of diabetic ulcers of the large square is square and severity, which in modern clinical practice is recognized, in particular, is a very knotty problem, the efficiency was amazing. Also, there is a very significant therapeutic efficacy in the treatment of secondary ulcers suffered the amputation wound surface after the first amputation of the lower extremities in diabetic patients.

Methods clinical embodiments below.

1. How to bandage

Directly on the wound surface diabetic ulcers layer applied ointment pharmaceutical compositions of the present invention with a thickness of 1-3 mm, the Wound surface was covered and bandaged (not very tight), using cotton gauze (or other similar ventilated material), with the replacement of bandages twice a day, morning and evening, or once a day (when in a less favourable conditions). Replacement of the dressing material specified in this description, means the first, very careful removal of metabolites from the wound surface diabetic ulcers and the remaining pharmaceutical compositions using a cotton Turunc, then applying to the wound a new one, but the same pharmaceutical composition, and finally blocks new gauze bandages. When the wounded wound surface appears some of oticheskaya muscle-tendon tissue, you must remove it with scissors. Throughout the treatment, do not use disinfectant substances for disinfection wounded wound surface.

2. The way public exposure

Directly on the wound surface diabetic ulcers layer applied ointment pharmaceutical composition of the present invention, typically of a thickness of less than 2 mm After application of the pharmaceutical composition wounded the wound was left open; after that, apparently, the pharmaceutical composition is deposited on the wounded wound surface begins to heat up and melt, some of the metabolites formed under the action of leukocytes in the wound surface, also begin to escape from the layer of the medicinal product or mixed with the pharmaceutical composition. In the end, all of the pharmaceutical composition on the wound surface will be converted into a mixture of metabolites formed under the action of leukocytes within 6-8 hours, at this point you must remove the mixture of metabolites formed under the action of white blood cells, using a cotton toround and then again to put on the wounded wound surface a new portion of the same pharmaceutical composition. Replacement by a new pharmaceutical composition should be in all cases, to the Yes applicable pharmaceutical composition completely transformed into a mixture of metabolites, formed under the action of leukocytes. You must repeat this method until the healing of the wounded wound surface. When wound on the surface of the ulcer appears necrotic muscle-tendon tissue, you must remove it with scissors. Throughout the treatment, do not use disinfectant substances for disinfection wounded wound surface.

3. The method using gauze with medicine

The gauze was dipped in the melt pharmaceutical compositions of the present invention, after the latter was heated and melted, similar to the method of manufacturing a gauze impregnated with vaseline. On the wounded wound surface was applied the gauze with the pharmaceutical composition, and then were processed by the method with bandaging or semi-open exposure. The gauze was changed once a day.

Diabetes is a disease characterized by chronic hyperglycemia. Also frequently reported related ulcers in the lower extremities, slow healing of wounds and other complications. Modern methods most diabetic ulcers can often lead to amputation, which is one of the main causes of disability and death in diabetic patients. There is a direct is whether mediated the relationship between hyperglycemia, which is the most important characteristic of diabetes, and the difficulty of healing wounded wound surface. Strict control of blood sugar can effectively prevent the emergence and manifestation of the difficulties heal the wound surface, but in many patients, even if the blood sugar level is regulated in the normal range, the healing of diabetic ulcers is still very difficult. With this in mind it is very important to conduct further research on the study of the mechanism of difficult healing of diabetic ulcers and to find effective and new way to improve the healing of diabetic ulcers. In the past, diabetic ulcers are often treated with surgery replacement of the dressing material, the efficiency of which is not always ideal.

The present invention shows that effective regulation of blood sugar pharmaceutical compositions of the present invention can significantly stimulate the healing of diabetic ulcers.

Linoleic acid as the active ingredient in the pharmaceutical compositions of the present invention is a type of essential fatty acids and essential component of the plasma membrane. She is also an indispensable material for cell repair after tissue injury, it can have elicitate the supply of nutrients to locally inflammatory wound surface and to provide essential nutrients to repair cells to the wound surface. Diabetes is a type of neurotrophic and metabolic diseases. Diabetic ulcers always occur on the toes, ankles and heels, indicating that the pathogenesis is closely associated with peripheral angiopathy peripheral and neurotopia.

The basic measure for the local treatment of diabetic ulcers is timely removal of necrotic tissue, since the surface of the chronic ulcers easily becomes dry, so clean it's not easy. Removal of necrotic tissue by surgery will damage part of normal tissue, especially if the fabric is exposed to severe ischemia due to the use of anesthetics containing epinephrine. For the pharmaceutical compositions of the present invention the preferred ointment form using the frame configuration. It is characterized by the oils and moisture that may remain in the wound surface for a long time, to keep the wound moist and promote enzymatic splitting and rancidification of necrotic tissue, and finally the secret of the wound surface is displayed by "samokonasana", which is very favorable for the removal of necrotic tissue. It also creates a physiological environment for the differentiation of stem cells in situ, which leads to activation of the resting stem cells and tissue regeneration, consequently prevents the formation of scar and spiloptera. The dilution and removal of necrotic tissue lasts a little longer than usual ulcers. Short-term action method with the dressing can also be taken before the wound begins to sajustice. Every time you can use a relatively large dosage of a layer thickness of more than 1.5 mm When necrotic tissue begins to be liquefied and removed, you must go to the open exposure to moisture, to reduce the dosage in each moment of time and to increase the duration of injection. Sign changes of diabetic ulcers in the treatment using the method of open exposure to moisture is that the dilution and removal of necrotic tissue is accompanied by the formation of permeable membrane lipoproteins. As soon as the permeable membrane is formed, begins the healing of ulcers. Special attention should be paid to the protection of the integrity of this permeable membrane lipoproteins, to ensure that the whole process of ulcer healing will always be carried out under this permeable membrane of lipoprotein. Once formed the main fabric of the skin permeable membrane lipoprotein izcheznet itself. Many of the cases in the present invention, the ri are diabetic ulcers can penetrate deep into the fat layer, characterized by a longer course of the disease, but can still be cured. One of the mechanisms according to which a diabetic ulcer can be cured is the regeneration of basal cells in the wounded wound surface, and the other is the concentric growth of new skin around the ulcer.

Surface-active agent in the pharmaceutical compositions of the present invention contains a hydrophilic group and lipophilic non-polar group; the pharmaceutical composition of the present invention has a higher surface activity and provides solubilizers effect (Rongxiang Xu. Regenerative medicine: research, creation and prospect. Chinese Journal of Burns, Wounds and Ulcers, 2002, 14(2): 122-130). As a result of this two-stage transformation of the pharmaceutical compositions of the present invention wounded wound surface effectively isolated, whereby is fighting infection, i.e. decreases bacterial infection, the bacteria lose contact with living tissue, therefore, effectively reduces the number of bacteria and inhibited bacterial growth with final effect of blocking, inhibiting, and removal of these bacteria. Effective insulation ulcers by using ointment also helps to maintain the enzymatic activity reduces and blocks the oxidation of unsaturated who's fatty acids and vitamin C, and effectively prevents the formation of peroxides, protects cell membranes and fats from oxidative damage and plays a role in maintaining normal tissue metabolism.

The pharmaceutical composition of the present invention effectively isolates the wounded wound surface and avoids irritating effect of external factors on the exposed areas of nerve endings, causing an analgesic effect. Besides the fact that the layer pharmaceuticals blocks irritating influence of external objects on the wound surface, there are other mechanisms that are involved in the specified analgesic effect: (1) beta-sitosterol and other ingredients in the pharmaceutical compositions of the present invention can effectively attenuate the inflammatory response; (2) self pharmaceutical agent is not irritating; (3) the pharmaceutical agent improves local microcirculation, increases local blood circulation, stimulates the local metabolism, weakens the incentive effect of tissue ischemia, anoxia, swelling on the nerve endings; (4) in addition to creating a physiological environment for the differentiation of stem cells in situ, which leads to activation of dormant stem cells and tissue regeneration, and all of it helps in the healing of ulcers.

The usefulness of the clinical application of pharmaceutical compositions for the present and the attainment of lies, as shown below, in the following:

1) the improvement of oxygen supply diabetic wounded wound surface, especially the surface of a large area, ulcerated wound and tissue with severe diabetes, which prevents the wound from anoxia and lack of ability to oxygenation and viability;

2) relatively fast growth of viable granulation tissue;

3) gradual regeneration again saulenas tissue on the wound surface of skin from the state of granulation tissue.

In conclusion, the present invention fills the gaps in the treatment of diabetic ulcers of pharmaceuticals in modern clinical medicine.

Brief description Photos

Figure 1. Photography diabetic ulcers on left outer ankle diabetic patient described in Example 7.

Figure 2. Photography medical gauze coated with paste and ointment, applied to the ulcer diabetic patient described in Example 7.

Figure 3. Photo of the progress of treatment of an ulcer on left outer ankle diabetic patient described in Example 7.

Figure 4. Photo of the progress of treatment of an ulcer on left outer ankle diabetic patient described in Example 7.

Figure 5. Photo of the progress of treatment of an ulcer on left outer ankle diabetic patient described in Example 7.

6. Photograph of the ulcer on the left inner ankle diabetic patient described in Example 8.

7. Photography medical gauze coated with paste and ointment, applied to the ulcer diabetic patient described in Example 8.

Fig. Photography applied pastes and ointments on the ulcer diabetic patient described in Example 8.

Fig.9. Photography diabetic ulcers before treatment diabetic patient described in Example 9.

Figure 10. Photo of diabetic ulcers in the middle of treating a diabetic patient described in Example 9.

11. Photography diabetic ulcers after treatment diabetic patient described in Example 9.

Fig. Photography diabetic ulcers before treatment diabetic patient described in Example 10.

Fig. Photography diabetic ulcers after treatment diabetic patient described in Example 10.

Fig. Photography diabetic ulcers after treatment diabetic patient described in Example 10.

Fig. Photography diabetic ulcers after treatment diabetic patient described in Example 10.

Fig. Photo treatment using the patch for a diabetic patient described in Example 11 Incarnations.

Fig. The photo on the 31st day after treatment diabetic patient described in Example 11.

Fig. Photog afia on the 60th day after the treatment of a diabetic patient described in Example 11.

Fig. The photo on the 90th day after treatment diabetic patient described in Example 11.

Fig. Photography at 110 days after treatment diabetic patient described in Example 11.

Incarnation

Next, using the attached photos, the present invention will be clarified by the following non-limiting examples. All the specialists in the art will know and agree that to the present invention, without deviating from the essence of the present invention, can be made of numerous modifications, however, even in this case, all these modifications will also fall into the category of the present invention.

Besides, the whole raw material, including Huangqin, Huanglian, Huangbai, earthworm and poppy box, sesame oil can easily be found on sale.

Example 1

In accordance with the method disclosed in Example 1 in the patent of China ZL931002761, and in accordance with the described and disclosed the same raw material is prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy pods. Mixing the above prepared on the basis of sesame oil extract and beeswax, preparing a Pharmaceutical composition 1 described in the present invention.

Example 2

In the accordance with the same method which is described in the patent of China ZL931002761, prepare the pharmaceutical composition described in the present invention, except that the use of samples Huanglian, Huangqin and Huangbai 10 kg each, earthworm and poppy pods 2 kg each, 100 kg of sesame oil and 10 kg of beeswax. Mixing beeswax and prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, prepare a Pharmaceutical composition 2.

Example 3

In accordance with the same method described in Example 1 of the present invention, preparing the pharmaceutical composition described in the present invention, except that the use of samples Huanglian, Huangqin and Huangbai 8 kg each, earthworm and poppy boxes 3 kg each, 100 kg of sesame oil and 8 kg of beeswax. Mixing beeswax and prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, prepare a Pharmaceutical composition 3.

Example 4

In accordance with the same method that is described in the patent of China ZL931002761, prepare the pharmaceutical composition described in the present invention, except that the use of samples Huanglian, Huangqin and Huangbai 3 kg each (the samples made in this area), earthworm and poppy boxes of 4 kg each, 10 kg of sesame oil and 15 kg of beeswax. Mixing beeswax and prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, prepare a Pharmaceutical composition 4.

Example 5

In accordance with the same method described in Example 3 of the present invention, preparing the pharmaceutical composition described in the present invention, except that the use of samples Huanglian, Huangqin and Huangbai 10 kg each, earthworm and poppy boxes of 10 kg each, 100 kg of sesame oil and 3 kg of beeswax. Mixing beeswax and prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, prepare a Pharmaceutical composition 5.

Example 6

The pharmaceutical compositions of the present invention, prepared in Example 1-5, heated and melted. In accordance with the method, known to specialists in this field, medical gauze is dipped directly into the melt of each of the five pharmaceutical compositions, respectively, as long as she is not fully saturated, thus preparing dressings containing pharmaceutical compositions of the present invention. Dressings were Packed, suitable for receiving sales of medical products.

Example 7

Treatment of ulcers of the soft tissue of the ankle Wu di is eticeskaja patient

Diabetic patient, a man aged 59 years, within 2 years suffering from ulcers area of approximately 44 cm on the left outer ankle (see Figure 1), with a documented diagnosis of diabetic ulcers. After hospitalization applied expectant therapy to reduce blood sugar and used medical gauze, described in Example 6 prepared using pharmaceutical compositions made in accordance with the method described in Example 1. On the wounded wound surface was applied the paste and covered bandages (see Figure 2 and Figure 3), which was changed once a day. The patient was cured and discharged after treatment for one month (see Figure 4 and Figure 5).

Example 8

Treatment of ulcers of the soft tissue of the ankle in a diabetic patient

Diabetic patient, a man aged 58 years, within 2 years suffering from ulcers area of approximately 3.54 cm on the left inner ankle (see Fig.6), with a documented diagnosis of diabetic ulcers. After hospitalization applied expectant therapy to reduce blood sugar and used medical gauze, described in Example 6 prepared using pharmaceutical compositions made in accordance with the method described in Example 2. On the wounded wound surface applied p is STU and covered bandages (see 7), which was changed once a day. The patient was cured and discharged after treatment for one month (see Fig).

Example 9

Treatment of diabetic foot ulcers

Diabetic patient, a woman aged 42 years, has come on reception to the doctor after ulceration of the foot of the left leg, which lasted for 22 days, which has grown dramatically. Doctors had recommended amputation, which had been rejected. At hospitalization blood sugar on an empty stomach early in the morning was one-22.67 mmol/l, and the patient in the clinic confirmed the diagnosis of diabetes. On the inner and lower portion of the left foot appeared a severe diabetic ulcer with significant swelling of the left foot, intensive ulceration extending from the outer part of the back surface of the foot to the middle and rear part of the sole, thus formed and joined fistulous passages, exposing the phalanges of the toes, began necrosis of the fascia and muscles, ulceration and secretion of foul-smelling odor (see Fig.9). After conducting anti-infective therapy and nutrition support therapy to the patient on the plague struck the pharmaceutical composition described in Example 3, a layer of ointment thickness of approximately 2 mm, after which the wounded wound surface, which was covered by pharmaceutical composition, kept fully open. The pharmacy is practical tool was changed once a day (see Figure 10). After treatment within 45 days of the plague was mostly healed, and the patient was discharged from the hospital (see 11).

Example 10

Treatment of diabetic foot ulcers

A man, suffering from diabetes for many years, did not conduct a very good control of blood sugar levels in everyday life, in his left ankle was clinically diagnosed diabetic ulcer, the inner part of the distal end of the left foot was clearly red and swollen, there were open wounds on the big toe and interphalangeal joint, joint capsule was damaged, it was possible to see the articular surfaces of the bones, there were necrotic tissue, attached to the inside of the distal end of the bone, muscle tendon was swollen and changed the natural properties. Was the wound surface 86 cm on the sole, fetid odor and isolation (see Fig). The patient on the plague struck the pharmaceutical composition described in Example 4, a layer of ointment thickness of approximately 1.5 mm, after which the wounded wound surface, which was covered by pharmaceutical composition, kept fully open. Pharmaceutical medium was changed once a day. After treatment for 35 days this ulcer was healed, and the patient was discharged from the hospital (see Fig, Fig, Fig).

Example 11

Treatment diabetics the th foot ulcers

Xu, male, aged 59, suffered from diabetes for 20 years. He has come on reception to the doctor in the Chinese regional hospital because he gangrene diabetic foot. The doctor advised him amputation, which he did not agree, and then he was transferred to the First clinical hospital, an affiliate of the Medical University in Harbin city. Upon admission she was diagnosed with: (1) type I diabetes; (2) diabetic gangrene of the right foot due to arterial obliteration on the right leg for six months. After treatment ulcerated wound patients were treated by topical form of the pharmaceutical composition described in Example 2, and the shape of the patch (containing the pharmaceutical composition described in Example 3), described in Example 6 (see Fig). Pharmaceutical medium was changed once a day and ulcer were treated with ointment and plaster, alternatively, after exposure. Healing wounded wound surface was gradually [see Fig (31 days), Fig (60 days)], 90 day ulcerated wound surface essentially healed (see Fig). After treatment within 110 days of healing wounded wound surface was good (see Fig).

Example 12

Monitoring of therapeutic efficacy on diabetic ulcers of the lower extremities in 60 cases the

Of the 60 cases of diabetic ulcers on the leg 36 of the cases belonged to men and 24 women. All patients aged 60 to 80 years had symptoms of polyposis, diuresis, polyphagia, physical inactivity, and so on. Repeated tests showed that the level of fasting blood sugar exceeded 7.8 mmol/l, which corresponded to the diagnosis of type II diabetes. Among all cases in which ulcers of the lower extremities lasted from 1 month to 26 months, 15 was an acute ulcer, 45 was a chronic ulcer. Among all of the latter, who received treatment in other hospitals, there were 36 cases of ulcers of the fingers of the feet, 9 cases, each of them consisted of heel ulcers and sores hocks, and 6 cases pretibial ulcers. All foot ulcers were chronic and characterized by deep penetration into the fat layer, and wounded wound surface had no granulation tissue, were dry and contained a small amount of exudate. The minimum size was 2.0 cm1.0 cm, and the maximum size was 2.2 cm5,5 see foot Ulcers were surrounded by a thick and solid monolaurate cloth. In 5 of 6 cases pretibial ulcers cause was external wounds, all smaller than 2.0 cm3.5 cm, with obvious redness, swelling, itching and pain in the skin around the wounds. All cases were divided into two groups randomly: 30 cases studied GRU is dust and 30 cases in the control group. There was no significant difference (P>0.05) in the statistics between the two groups on age, gender, phase of the disease and the size of the ulceration was not. With regard to the treatment of primary disease, in addition to enhancing diet for all cases used methods of reducing blood sugar levels, using appropriate medications. To avoid hypoglycemia and lactacidemia in elderly patients, gave acarbose. Regularly tested concentration of sugar in the blood and in accordance with this adjust treatment plans. The most ideal therapeutic effect against primary disease is that the concentration of sugar in the blood is reduced to less than 8.3 mmol/L.

In the study group (test group) wounded wound surface and the skin around it was dezynfytsyrovaly 1%povidone-iodine, washed with sterile saline solution and perform the cleansing of necrotic tissue using sterile forceps and scissors, then washed with sterile saline or 3%hydrogen peroxide solution. All ulcers in the study group externally and topically applied evenly povidone-iodine, leaving the drug to penetrate into the fabric within 1-2 minutes. Then the pharmaceutical composition of the present invention, described in Example 1, were treated ulcers with in which the shaft Turunc, put a thin uniform layer, supporting layer thickness from 1.5 mm to 2.0 mm In the ointment was placed sterile gauze, bandaging. Holding the legs in an elevated position, once a day changed the pharmaceutical agent. When necrotic tissue began to liquefied, this treatment strategy was changed on the way of open exposure to moisture. When using a layer thickness of 1.0 mm, the pharmaceutical agent was changed twice a day. Liquefied necrotic tissue was removed, every time spent replacing pharmaceuticals.

In the control group sterile gauze impregnated with gentamicin in the number 160000 units and then applied on the wounds, which were bandaged bandages once a day. When replacing liquefied mixture or necrotic tissue should be removed from ulcers in both groups up until granulation tissue does not become grey and has not yet reached full epithelialization.

To determine the extent of healing of the wounded wound surface, to calculate the area lacerated wound surface using the method of charting and transparent lined paper, see detailed references to software packages Adobe Photoshop 7.0 and Osiris. The area before treatment was selected as the initial square, and the square at the end of the study - ka is este space at a specific moment in time phases (eng. time phase point area). The formula for calculating the area: cured size=(initial size) - (size at a specific moment in time phases); the degree of healing of ulcerated wound surface=(cured area / affected area) 100%. Healing + obvious effectiveness + efficiency = overall efficiency. Healing: complete epithelialization, no exudate; obvious efficiency: the degree of healing is more than 80%, no secret, granulation tissue grows, fresh and with a predisposition to bleeding; efficiency: wounded wound be reduced, but not greater than 80%, the amount of exudate decreases, granulation tissue grows, pale and stale; inefficiency: wounded wound surface without changing or even increased, stale.

During statistical processing all data were expressed as(xS). Statistical analysis, including f-test, X2-test and correlation analysis for statistical data was performed using software SPSS11.0. P<0,05 characterizes statistical significance.

Among the above-mentioned cases 6 cases pretibial ulcers healed within 4 weeks and the course of healing was similar to that for deep second-degree burns. Leather, sagusa in this place, even. The smallest duration of healing of chronic ulcers on the toes and heels was 35 days, and the longest 2 months. According to clinical observation full speed healing of this type of ulcer can be divided into three stages: the dilution and removal of necrotic tissue; education permeable lipoprotein membrane; and regenerative healing. The length of time required for the dilution and removal of necrotic tissue, associated with the types of primary diseases and increased necrotic ulcerous wound surface, however, all necrotic tissue may begin to liquefied after treatment for 3-4 days, and the dilution and removal of the can end within 2-4 weeks. The second and first stages are interrelated, i.e. permeable lipoprotein membrane develops gradually in the process of liquefaction and removal of necrotic tissue, and the dilution and removal of necrotic tissue ends when permeable lipoprotein shell is completely generated. As soon as permeable lipoprotein membrane is formed, regenerative healing begin to accelerate, which will be noticeable to the naked eye, with the growth and development plasticating processes of the skin or of skin islets. In the treatment motolora the tissue surrounding the wound surface, tapeno will otshelushivatsya, will appear and concentrically to grow again growing skin, finally, the wounded wound surface will be zajivlenie.

Table.
Comparison of therapeutic efficacy between the two groups
Group# Of timesHealingThe apparent effectivenessEfficiencyInefficiencyThe overall effectivenessThe average time to healing (days)
Control. group30912632747,3020,40
Tester. group30272103025,0010,50

Note: X2test for table data row column was used to compare the extent led the ins X 2for the effectiveness and degree of healing are 22,71 and 20,07, respectively, all of which are more thanX0,052=12,84therefore P<0,05; X2-test also was used to compare average healing times t=5,32, P<0,01.

Example 13

The kind of medical first aid kits were prepared using the pharmaceutical composition produced in Example 1 or dressing material made in Example 6 in a manner known in the art. Finally, print the instructions for use were combined with appropriately packaged pharmaceutical compositions (e.g., ointment) or specified dressing material (e.g., patch), and after packing the first aid kit was suitable for sale.

1. The use of pharmaceutical compositions in the manufacture of pharmaceutical agents for the treatment of diabetic ulcers in the field of limb or on the body surface or in the manufacture of bandages, where the pharmaceutical composition comprises (A) 3-15 wt.% food beeswax and (C) 85-97 wt.% prepared on the basis of sesame oil extract of Huangqin (Huang-Qin), Huanglian (Juan-lane), Huangbai (Huang Bai), earthworm and poppy capsule, based on the total weight of f is rmaceuticals composition, in prepared on the basis of sesame oil extract of a number of Huangqin, Huanglian, Huangbai, earthworm and poppy boxes is 2-10 wt.% based on the total weight of sesame oil, where
specified Huangqin is a root of Baikal skullcap (Scutellaria baicalensis Georgi),
specified Huanglian is a rhizome of coptis Chinese (Coptis chinensis Franch), coptis deltoid (C.deltoidea C.Y. Cheng et Hsiao) or Coptis. teeta Wall,
specified Huangbai represents the crust velvet Chinese tree (Phellodendron chinense Schneid) or velvet tree Amur (P.amurense Rupr.).

2. The use according to claim 1, wherein the specified pharmaceutical composition is an agent for external use.

3. The use according to claim 2, in which the specified agent for external use contains the agent in the form of oil, emulsion, paste, patch or gel.

4. The use according to claim 1 or 2, wherein the specified pharmaceutical composition further contains a pharmaceutically acceptable carrier.

5. The use according to claim 1, wherein the specified dressings contains medical cotton gauze or medical bandage.

6. Dressings for the treatment of diabetic ulcers in the field of limb or on the body surface, where the specified dressings provides a pharmaceutical composition comprised the total of: (A) 3-15% food grade beeswax and (B) 85-97% prepared on the basis of sesame oil extract of Huangqin, Huanglian, Huangbai, earthworm and poppy capsule, based on the total weight of the pharmaceutical composition, prepared on the basis of sesame oil extract of a number of Huangqin, Huanglian, Huangbai, earthworm and poppy boxes is 2-10 wt.% based on the total weight of sesame oil, where
specified Huangqin is a root of Baikal skullcap (Scutellaria baicalensis Georgi),
specified Huanglian is a rhizome of coptis Chinese (Coptis chinensis Franch), coptis deltoid (C.deltoidea C.Y. Cheng et Hsiao) or Coptis. teeta Wall,
specified Huangbai represents the crust velvet Chinese tree (Phellodendron chinense Schneid) or velvet tree Amur (P.amurense Rupr.).

7. The dressing material according to claim 6, which contains medical cotton gauze or medical bandage.

8. The dressing material according to claim 6 or 7, in which the specified pharmaceutical composition comprises an agent in the form of oil, emulsion, paste, patch or gel.

9. The dressing material according to claim 6 or 7, in which the specified pharmaceutical composition further contains a pharmaceutically acceptable carrier.

10. First aid kit for the treatment of diabetic ulcers in the field of limb or body surface, comprising a pharmaceutical composition according to claim 1 or bandaging material according to claim 6 and the instructions for use.



 

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7 cl, 11 ex, 1 tbl

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13 tbl, 3 ex

FIELD: medicine, pharmaceutics.

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2 ex

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Burn ointment // 2523551

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7 ex

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2 ex

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2 cl, 16 dwg, 9 tbl

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11 cl, 7 tbl, 12 ex

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FIELD: chemistry.

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4 ex

FIELD: medicine.

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FIELD: medicine.

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1 cl

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2 ex

FIELD: medicine.

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EFFECT: method enables improving and stabilising the clinical measures of the active products of the oral fluid due to a synergetic effect of the substrate components.

4 tbl, 1 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to the pharmaceutical industry, namely to a personal preparation from earthworms for treatment of diabetes. The method of obtaining the personal preparation from earthworms for treatment of diabetes includes placement of sexually mature earthworms in a medium, consisting of organics, which additionally contains a solution of a patient's urine, after that, the sexually mature earthworms are removed and for 3 months each 7-10 days fresh organic food is added to the remaining mass, after that, the sexually mature earthworms are separated, placed in a reservoir and sprayed with an alcohol solution, mixed, poured with the alcohol solution and placed into dark place under the specified temperature, with the solution being mixed daily, with further separation of the extract from the sediment. The personal preparation for treatment of diabetes.

EFFECT: application of the described above preparation increases efficiency of diabetes treatment.

3 cl, 3 dwg, 1 ex

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